Relapsed/Refractory Multiple Myeloma (RRMM)NCT07497165
Epunamin Combined With DECP for Relapsed/Refractory Multiple Myeloma
An observational study of Relapsed/Refractory Multiple Myeloma (RRMM) and Multiple Myeloma, run by Shanxi Bethune Hospital at 1 site in China.
Trial summary
Background: Multiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed/refractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (RRMM), Multiple Myeloma
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Jun 2027
- How long will I take part?
- 17 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: relapsed/refractory Multiple Myeloma
Who may be able to join
- Adults aged 18 to 75 years with relapsed/refractory Multiple Myeloma diagnosed according to revised IMWG criteria.
- Received at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance.
- Provided written informed consent. -
Who cannot join
- Severe dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction <50%, diffusion capacity for carbon monoxide <50% of predicted value due to chronic respiratory disease, serum bilirubin >2 mg/dL, alanine aminotransferase or aspartate aminotransferase >2.5 × upper limit of normal, or estimated glomerular filtration rate <30 mL/min.
- Toxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment.
- High-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance.
- Pregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose.
- Diagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide.
- Human Immunodeficiency Virus Infection positive. Participation in another clinical trial within 30 days before enrollment or during the study period.
- Any condition considered unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
ShanxiBethuneH
Taiyuan, Shanxi, 030000
Tian Weiwei Tian Weiwei, PhD, +156-13485304136, tianweiwei@yesh.net
About this study
Official title: A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed/Refractory Multiple Myeloma
Background:
Multiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed/refractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting.
Read more
Methods:
This multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent.
Key exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators.
Endpoints:
The primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria.
Statistical Analysis:
Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value <0.05 will be considered statistically significant.
Study Period:
October 2025 to September 2027.
Read the detailed description
Background:
Multiple Myeloma remains an incurable plasma cell malignancy, and patients with relapsed/refractory disease continue to face limited therapeutic options and poor clinical outcomes. Epunamin, in combination with a DECP-based regimen, may provide a novel therapeutic strategy in this setting. However, evidence from real-world clinical practice remains limited.
Methods:
This is a multicenter, single-arm, real-world observational clinical study designed to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in patients with relapsed/refractory multiple myeloma (RRMM). A total of 48 eligible patients aged 18-75 years who meet the revised International Myeloma Working Group diagnostic criteria and have received at least one prior systemic therapy will be enrolled. Eligible participants must have an Eastern Cooperative Oncology Group performance status of 0-3 and provide written informed consent.
Major exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved toxicities from prior chemotherapy; grade ≥2 peripheral neuropathy; active severe infection; plasma cell leukemia; concurrent malignancies diagnosed within 2 years; HIV infection; pregnancy or lactation; and known hypersensitivity to study drugs.
Endpoints:
The primary endpoint is overall response rate (ORR) after completion of four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), based on laboratory findings and revised IMWG criteria.
Statistical Analysis:
Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Categorical variables will be presented as counts and percentages. Normally distributed continuous variables will be analyzed using Student's t-test or analysis of variance, while non-normally distributed variables will be compared using rank-sum tests. Categorical variables will be analyzed using the chi-square test or Fisher's exact test. Ordinal variables will be assessed using Ridit analysis or nonparametric rank-sum tests. Survival outcomes, including progression-free survival (PFS) and overall survival (OS), will be estimated using the Kaplan-Meier method, with comparisons performed using the log-rank test. All statistical analyses will be two-sided, with P < 0.05 considered statistically significant.
Study Period:
Patient enrollment and follow-up are planned from October 2025 to September 2027.
- Keywords
- Epunamin, DECP-Based Regimen, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Epunamin Combined With DECP-Based Regimen | Patients with relapsed/refractory Multiple Myeloma will receive Epunamin in combination with a DECP-based regimen as follows: Epunamin 10 mg/kg administered on days 1-5, or days 1-3 and days 15-17 Cisplatin 10 mg/m² on days 1-4 Etoposide 40 mg/m² on days 1-4 Cyclophosphamide 300 mg/m² on days 1-4 Dexamethasone 20-40 mg on days 1-4 Each treatment cycle lasts 28 days. Patients achieving clinical benefit will receive at least 4-6 cycles of treatment. For first administration, Epunamin will be introduced using a step-up dosing strategy, particularly in patients with high tumor burden or extramedullary bulky disease. The DECP regimen will start at 1/2 to 2/3 of the standard dose, and in patients older than 70 years, treatment will begin at 1/2 dose.During treatment, thromboprophylaxis with low-molecular-weight heparin or Rivaroxaban will be administered to prevent thrombotic events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) is defined as the proportion of evaluable patients who achieve complete response (CR) or partial response (PR) after treatment.
Formal efficacy evaluation will be performed at the end of cycle 4. M-protein and related laboratory parameters will be monitored during each treatment cycle, while bone marrow examination and serum free light chain assessment will be performed every 2 cycles to evaluate depth of response.
Measured: At the end of cycle 4 (approximately 4 months) Description
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
- Target duration
- 17 Months
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiwei Tian, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497165
- Sponsor's protocol ID
- IIT-2025-121-KS043
- Status last verified
- Oct 2025
- First submitted
- 23 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing is not planned because the collected data contain sensitive clinical information, and data access is restricted in accordance with institutional policies and patient confidentiality requirements.
Publications
Gamie Z, Kapriniotis K, Papanikolaou D, Haagensen E, Da Conceicao Ribeiro R, Dalgarno K, Krippner-Heidenreich A, Gerrand C, Tsiridis E, Rankin KS. TNF-related apoptosis-inducing ligand (TRAIL) for bone sarcoma treatment: Pre-clinical and clinical data. Cancer Lett. 2017 Nov 28;409:66-80. doi: 10.1016/j.canlet.2017.08.036. Epub 2017 Sep 6.
PubMed 28888998NCCN Guidelines Version 3.2024 Multiple Myeloma[M].2024
Xia Z, Leng Y, Fang B, Liang Y, Li W, Fu C, Yang L, Ke X, Jiang H, Weng J, Liu L, Zhao Y, Zhang X, Huang Z, Liu A, Shi Q, Gao Y, Chen X, Pan L, Cai Z, Wang Z, Wang Y, Fan Y, Hou M, Ma Y, Hu J, Liu J, Zhou J, Zhang X, Meng H, Lu X, Li F, Ren H, Huang B, Shao Z, Zhou H, Hu Y, Yang S, Zheng X, Wei P, Pang H, Yu W, Liu Y, Gao S, Yan L, Ma Y, Jing H, Du J, Ling W, Zhang J, Sui W, Wang F, Li X, Chen W. Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT-MM301): a randomised, double-blinded, placebo-controlled, phase 3 trial. BMC Cancer. 2023 Oct 14;23(1):980. doi: 10.1186/s12885-023-11489-8.
PubMed 37838670Globocan, The Global Cancer Observatory (GCO) (2020a) Cancer Today; World Fact Sheets. 2020.
Rajkumar SV. Multiple myeloma: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Aug;97(8):1086-1107. doi: 10.1002/ajh.26590. Epub 2022 May 23.
PubMed 35560063
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07497165
- Acronym / sponsor ID
- IIT-2025-121-KS043
- Keywords
- Epunamin, DECP-Based Regimen, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Multiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed/refractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting.
Methods:
This multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent.
Key exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators.
Endpoints:
The primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria.
Statistical Analysis:
Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value <0.05 will be considered statistically significant.
Study Period:
October 2025 to September 2027.
Detailed description
Background:
Multiple Myeloma remains an incurable plasma cell malignancy, and patients with relapsed/refractory disease continue to face limited therapeutic options and poor clinical outcomes. Epunamin, in combination with a DECP-based regimen, may provide a novel therapeutic strategy in this setting. However, evidence from real-world clinical practice remains limited.
Methods:
This is a multicenter, single-arm, real-world observational clinical study designed to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in patients with relapsed/refractory multiple myeloma (RRMM). A total of 48 eligible patients aged 18-75 years who meet the revised International Myeloma Working Group diagnostic criteria and have received at least one prior systemic therapy will be enrolled. Eligible participants must have an Eastern Cooperative Oncology Group performance status of 0-3 and provide written informed consent.
Major exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved toxicities from prior chemotherapy; grade ≥2 peripheral neuropathy; active severe infection; plasma cell leukemia; concurrent malignancies diagnosed within 2 years; HIV infection; pregnancy or lactation; and known hypersensitivity to study drugs.
Endpoints:
The primary endpoint is overall response rate (ORR) after completion of four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), based on laboratory findings and revised IMWG criteria.
Statistical Analysis:
Continuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Categorical variables will be presented as counts and percentages. Normally distributed continuous variables will be analyzed using Student's t-test or analysis of variance, while non-normally distributed variables will be compared using rank-sum tests. Categorical variables will be analyzed using the chi-square test or Fisher's exact test. Ordinal variables will be assessed using Ridit analysis or nonparametric rank-sum tests. Survival outcomes, including progression-free survival (PFS) and overall survival (OS), will be estimated using the Kaplan-Meier method, with comparisons performed using the log-rank test. All statistical analyses will be two-sided, with P < 0.05 considered statistically significant.
Study Period:
Patient enrollment and follow-up are planned from October 2025 to September 2027.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Epunamin Combined With DECP-Based Regimen | – | –Patients with relapsed/refractory Multiple Myeloma will receive Epunamin in combination with a DECP-based regimen as follows: Epunamin 10 mg/kg administered on days 1-5, or days 1-3 and days 15-17 Cisplatin 10 mg/m² on days 1-4 Etoposide 40 mg/m² on days 1-4 Cyclophosphamide 300 mg/m² on days 1-4 Dexamethasone 20-40 mg on days 1-4 Each treatment cycle lasts 28 days. Patients achieving clinical benefit will receive at least 4-6 cycles of treatment. For first administration, Epunamin will be introduced using a step-up dosing strategy, particularly in patients with high tumor burden or extramedullary bulky disease. The DECP regimen will start at 1/2 to 2/3 of the standard dose, and in patients older than 70 years, treatment will begin at 1/2 dose.During treatment, thromboprophylaxis with low-molecular-weight heparin or Rivaroxaban will be administered to prevent thrombotic events. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- relapsed/refractory Multiple Myeloma
Key inclusion criteria (3 listed)
- Adults aged 18 to 75 years with relapsed/refractory Multiple Myeloma diagnosed according to revised IMWG criteria.
- Received at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance.
- Provided written informed consent. -
Key exclusion criteria (7 listed)
- Severe dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction <50%, diffusion capacity for carbon monoxide <50% of predicted value due to chronic respiratory disease, serum bilirubin >2 mg/dL, alanine aminotransferase or aspartate aminotransferase >2.5 × upper limit of normal, or estimated glomerular filtration rate <30 mL/min.
- Toxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment.
- High-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance.
- Pregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose.
- Diagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate (ORR) is defined as the proportion of evaluable patients who achieve complete response (CR) or partial response (PR) after treatment.
Time frame: At the end of cycle 4 (approximately 4 months) Description
Formal efficacy evaluation will be performed at the end of cycle 4. M-protein and related laboratory parameters will be monitored during each treatment cycle, while bone marrow examination and serum free light chain assessment will be performed every 2 cycles to evaluate depth of response.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 28888998Gamie Z, Kapriniotis K, Papanikolaou D, Haagensen E, Da Conceicao Ribeiro R, Dalgarno K, Krippner-Heidenreich A, Gerrand C, Tsiridis E, Rankin KS. TNF-related apoptosis-inducing ligand (TRAIL) for bone sarcoma treatment: Pre-clinical and clinical data. Cancer Lett. 2017 Nov 28;409:66-80. doi: 10.1016/j.canlet.2017.08.036. Epub 2017 Sep 6.
- BackgroundNCCN Guidelines Version 3.2024 Multiple Myeloma[M].2024
- Background: PubMed 37838670Xia Z, Leng Y, Fang B, Liang Y, Li W, Fu C, Yang L, Ke X, Jiang H, Weng J, Liu L, Zhao Y, Zhang X, Huang Z, Liu A, Shi Q, Gao Y, Chen X, Pan L, Cai Z, Wang Z, Wang Y, Fan Y, Hou M, Ma Y, Hu J, Liu J, Zhou J, Zhang X, Meng H, Lu X, Li F, Ren H, Huang B, Shao Z, Zhou H, Hu Y, Yang S, Zheng X, Wei P, Pang H, Yu W, Liu Y, Gao S, Yan L, Ma Y, Jing H, Du J, Ling W, Zhang J, Sui W, Wang F, Li X, Chen W. Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT-MM301): a randomised, double-blinded, placebo-controlled, phase 3 trial. BMC Cancer. 2023 Oct 14;23(1):980. doi: 10.1186/s12885-023-11489-8.
- BackgroundGlobocan, The Global Cancer Observatory (GCO) (2020a) Cancer Today; World Fact Sheets. 2020.
- Background: PubMed 35560063Rajkumar SV. Multiple myeloma: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Aug;97(8):1086-1107. doi: 10.1002/ajh.26590. Epub 2022 May 23.
- Individual participant dataSharing planned: Undecided. IPD sharing is not planned because the collected data contain sensitive clinical information, and data access is restricted in accordance with institutional policies and patient confidentiality requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed/Refractory Multiple Myeloma (RRMM) and Multiple Myeloma, run by Shanxi Bethune Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian Weiwei Tian Weiwei, PhD (+156-13485304136, tianweiwei@yesh.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) is defined as the proportion of evaluable patients who achieve complete response (CR) or partial response (PR) after treatment. (time frame: At the end of cycle 4 (approximately 4 months) Description). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07497165, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.